Trial Condition(s):
Urinary Tract Infections
A Phase IV study of Cipro XR in uncomplicated UTI (EXPRESS)
Bayer Identifier:
100534
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
Safety and efficacy of Cipro XR in a naturalistic setting and the effectiveness of an educational brochure. - Women with urinary tract infections were treated with Cipro XR. They were also given a brochure with information about urinary tract infections and later tested on the information.
Inclusion Criteria
- Ambulatory women outpatients 18 to 65 years of age with a documented clinical diagnosis of uUTI characterized by dysuria with either urgency or frequency. Women of childbearing age were enrolled only if they were highly unlikely to conceive during the study and were practicing a suitable method of birth control or were at least 1 year postmenopausal. - Positive leukocyte esterase (>/= 1+) and positive nitrite test using a urine dipstick method of analysis. - Willing to give written consent.
Exclusion Criteria
- Pregnant or nursing - Complicated UTI - Allergy to Cipro XR
Trial Summary
Enrollment Goal
7614
Trial Dates
Phase
4
Could I receive a placebo?
No
Products
Cipro XR (Ciprofloxacin, BAYQ3939)
Accepts Healthy Volunteers
No
Where to Participate
Locations
| Locations |
|---|
Trial Design
EXPRESS: Evaluating Cipro XR Patient Response, Education, Safety, and Satisfaction
Trial Type:
Interventional
Intervention Type:
Behavioral
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- To compare the effect on knowledge of uncomplicated urinary tract infection (uUTI) in patients who were given a disease-directed educational brochure to read versus patients who were not given the brochure.Timeframe: 3-10 days after start of therapy
Secondary Outcome
- To examine the difference between physician and patient perceptions of the symptoms of uUTI.Timeframe: At baseline visit pre-therapy
- To collect data on the clinical efficacy and safety of Cipro XR, 500 mg, PO once daily, for 3 days, in the treatment of uUTI in a naturalistic setting.Timeframe: 1-3 days after end of therapy for efficacy and up to 30 days for safety
Additional Information
Copyright © Bayer
Powered by
